Artelo Biosciences announces first-in-human data for ART26.12

Artelo Biosciences (ARTL) announced results from its first-in-human study evaluating ART26.12, a novel inhibitor of Fatty Acid Binding Protein 5. The results affirm the promising safety and pharmacokinetic profile previously observed in preclinical studies. Inhibiting FABP5 represents a unique mechanism of action with ART26.12 standing out as a first-in-class candidate in the field of pain management. The Phase 1 Single Ascending Dose study was designed to assess the safety, tolerability, and pharmacokinetics of ART26.12 in healthy volunteers. The SAD study enrolled 49 subjects. The key findings include: All adverse events were mild, transient, and self-resolving. No drug-related AEs were observed in the blinded dataset, and no tolerability issues or safety signals were detected across multiple assessments. Full dose-exposure profiles were successfully explored. Plasma analysis confirmed dose-dependent, linear absorption across the evaluated range. A wide safety margin was observed between estimated therapeutic plasma concentrations and the highest exposure levels achieved, supporting potential titration for maximum efficacy in future studies. Andrew Yates, CSO, commented, “We are greatly encouraged with the results of the SAD study with our lead FABP5 inhibitor and we are particularly pleased to observe that the safety and PK profile that had been generated from ART26.12’s non-clinical studies translated well to the human experience.”